<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190709044160N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-17</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Determination of the Effect of Crude Oil on Erectile Dysfunction in Men with Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Determination of the Effect of Crude Oil on Erectile Dysfunction in Men with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40729</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization is simple
unit of randomization is individual
tool used in randomization is table of random number, Blinding description: Medication and placebo without a label and in identical packs by a contributing designer who is not the person completing the questionnaire, is randomly distributed among the participants.</study_design>
      <phase>2</phase>
      <hc_freetext>The Effect of Crude Oil on the Treatment of Erectile Dysfunction in Men With Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Twenty-five men with MS who suffer from impotence and who are interfering with standard cigarette butts in Iran. First, the patient should wash the part of the area with water and soap to be thoroughly cleaned. After washing the skin, slowly massage for 10 minutes, so that the color of the skin reaches red, then drop a few drops of crude oil on the desired parts and begin to massage calmly. Make sure the oil is completely absorbed into the skin, massage at least 5 and not more than 10 minutes, and do it twice a day. At least one hour after that, the crust oil should remain on the skin and not washed. Intervention 2: Control group: Twenty-five men with MS who suffer from impotence and who are interfering with placebo. First, the patient should wash the part of the area with water and soap to be thoroughly cleaned. After washing the skin, slowly massage for 10 minutes, so that the color of the skin reaches red, then drop a few drops of placebo on the desired parts and begin to massage calmly. Make sure the placebo is completely absorbed into the skin, massage at least 5 and not more than 10 minutes, and do it twice a day. At least one hour after that, the placebo should remain on the skin and not washed.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The results of international index of erectile function that shares all the data after unidentifiable individuals.

When:
After completing the international index of erectile function

To whom:
Faculty Members of Medical Universities across Iran

Conditions:
With written request for reuse of files

Where to obtain:
Postcode: Kerman, Kowsar Blvd, Shafa Hospital,Abbas sanjari pour.Email:drsanjari1354@gmail.com phone number:09215974063

How to obtain:
The written and formal request of the applicant who has been approved by the research assistant at the university of the applicant's workplace will be sent no later than one week later.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Sanjaripour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa Medical and Education Center , Kowsar Blvd, Kerman.</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۶۱۸۷۵۱۱۵۱</zip>
        <telephone>+98 34 3211 5780</telephone>
        <email>drsanjari1354@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rostam Seyfaddini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa Medical and Education Center , Kowsar Blvd, Kerman.</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۶۱۸۷۵۱۱۵۱</zip>
        <telephone>+98 34 3211 5780</telephone>
        <email>drsanjari1354@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Man with multiple sclerosis disease and erectile dysfunction</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of erectile dysfunction before diagnosing multiple sclerosis
History of skin hypersensitivity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Twenty-five men with MS who suffer from impotence and who are interfering with standard cigarette butts in Iran. First, the patient should wash the part of the area with water and soap to be thoroughly cleaned. After washing the skin, slowly massage for 10 minutes, so that the color of the skin reaches red, then drop a few drops of crude oil on the desired parts and begin to massage calmly. Make sure the oil is completely absorbed into the skin, massage at least 5 and not more than 10 minutes, and do it twice a day. At least one hour after that, the crust oil should remain on the skin and not washed.</i_keyword>
      <i_keyword>Control group: Twenty-five men with MS who suffer from impotence and who are interfering with placebo. First, the patient should wash the part of the area with water and soap to be thoroughly cleaned. After washing the skin, slowly massage for 10 minutes, so that the color of the skin reaches red, then drop a few drops of placebo on the desired parts and begin to massage calmly. Make sure the placebo is completely absorbed into the skin, massage at least 5 and not more than 10 minutes, and do it twice a day. At least one hour after that, the placebo should remain on the skin and not washed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of men with multiple sclerosis that suffering erectile dysfunction. Timepoint: The IIEF questionnaire was completed at the beginning of the study and 3 months after the use of crude oil and placebo. Method of measurement: IIEF questionaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-08</approval_date>
        <contact_name>National Ethics Committee for Biomedical Research</contact_name>
        <contact_address>Shafa Medical and Education Center,Kowsar Blvd, Kerman ,Iran Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
